Northwestern University spinout Sibel Health has received FDA clearance for its flexible, wireless vital signs monitoring platform.

Sibel Health spun out of the Querrey Simpson Institute for Bioelectronics at Northwestern University in Illinois. It has received its first 510(k) clearance from the US Food & Drug Administration for the Anne One platform, a wireless, flexible and rechargeable monitoring system for measuring multiple vital signs in a healthcare setting.

For clinical decision-making by medical providers, it is suitable for patients 18 years or older. It includes a companion mobile device pre-loaded with Anne View software to visualise clinical data in real time.

Prior to FDA 510(k) clearance, the Anne One system has been deployed with thousands of patients across a wide range of geographic locations including low-resource settings. It has featured in scientific publications in Nature Medicine, Lancet Digital Medicine and Proceedings of the National Academy of Medicine.

With US government support, Sibel Health has also deployed the Anne One platform to assess patients with Covid-19.

“It’s so rewarding to see a cutting-edge technology go from scientific and technical proof of concept to FDA clearance, a hugely important milestone as we deploy Anne One clinically,” said Ha Uk Chung cofounder and VP of research and development at Sibel Health.

Jong Yoon Lee, cofounder and VP of software engineering, added: “The ability for our system to monitor a wide range of vital signs using a dual-sensor platform is very powerful and unique. The interoperability and the extendability of the system will allow us to use this approval as a foundation to expand to other novel indications and make monitoring accessible to everyone.”

Backed by a consortium of for-profit and non-profit strategic partners, Sibel’s Anne One platform offers a physiological monitoring with analytics for both clinical care and research applications. Sibel is headquartered in Niles, Illinois, with an office in Seoul, South Korea.